Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:42 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT02567435
Description: Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Frequency Threshold: 0
Time Frame: Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry.
Study: NCT02567435
Study Brief: Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regimen A (VAC/VI) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. 33 None 17 155 139 155 View
Regimen B (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. 33 None 77 153 141 153 View
Regimen C (FOXO1 Fusion Negative, VAC/VA) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. 0 None 0 3 1 3 View
Feasibility (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. 4 None 6 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCv5 View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCv5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Cecal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCv5 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv5 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Rectal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Sinusoidal obstruction syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCv5 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Tumor hemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv5 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCv5 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCv5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Conjunctivitis infective SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Corneal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv5 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv5 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Encephalitis infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Eyelid function disorder SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Fungemia SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCv5 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Genital edema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv5 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Herpes simplex reactivation SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Immune system disorders - Other, specify SYSTEMATIC_ASSESSMENT Immune system disorders CTCv5 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Injury, poisoning and procedural complications - Other, specify SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Large intestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Laryngeal hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv5 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Neck edema SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Oculomotor nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Optic nerve disorder SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Papilledema SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Perineal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Periorbital edema SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Peritoneal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Phantom pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Pharyngeal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Psychiatric disorders - Other, specify SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Reproductive system and breast disorders - Other, specify SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Salivary gland infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Small intestinal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Social circumstances - Other, specify SYSTEMATIC_ASSESSMENT Social circumstances CTCv5 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Superficial thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCv5 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Tendon reflex decreased SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv5 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Urostomy stenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View